MAUDE Adverse Event Report: APYX MEDICAL CORPORATION RENUVION

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pneumothorax (2012)

Event Date 12/10/2021

Event Type  Injury  

Event Description

It was reported that a (b)(6) patient with a history of morbid obesity with a weight loss from (b)(6) kg to (b)(6) kg, non smoker and small umbilical hernia, underwent liposuction, abdominal body lift, dorsal body lift, breast tuck and implants.Liposuction was performed to the abdomen, thighs, arms and back followed by subdermal coagulation also to the thighs, abdomen, back and arms.Gas settings were between 80%-100% to the back and 3 liters of flow, 80% gas and 2 liters of flow to the thighs, abdomen and arms.All areas were treated with the antegrade and retrograde technique and 4 passes were performed to each area treated.Insertion sites on the anterior surfaced were made in each inguinal fold (12mm), 1 incision in the umbilicus (5mm), 1 incision on the anterior side of each knee-patella (5mm).On the posterior surface incision sites were 1 inter-gluteal (15mm), 1 sub-gluteal (5mm), 1 interspecular incision (3cm because he addressed an old scar) and 1 incision on each posterior face of the elbow (5mm).Lipo-aspiration was performed to the abdomen and thighs: 500cc abdomen, 800cc for thighs, total anterior: 1.300cc, another 1.800cc for dorso-lombar region + arms.Grand total = 3.1 liters done in approximatively 3h.Treatment planes were 2 superficial + 2 deep with a mix of retrograde + both retrograde & anterograde passes.Patient experienced dyspnea and pain.She received oxygen, had x-ray that showed full pneumothorax.She was hospitalized and a chest tube was placed to treat the pneumothorax.The patient spent 3 nights at the hospital, and another 2 nights back at (b)(6).Patient status seems to be good.There was no allegation of device malfunction.

• Brand Name: RENUVION
• Type of Device: RENUVION
• Manufacturer (Section D): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer (Section G): APYX MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• Manufacturer Contact: aylin canlar ; 5115 ulmerton road; clearwater, FL 33760-4004 ; 7273842323
• MDR Report Key: 13194132
• MDR Text Key: 288628940
• Report Number: 3007593909-2021-00036
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 73 KG